Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty

Prospective Randomized Controlled Trial Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty

This study aims to compare the efficacy of different doses of glucocorticoids in local infiltration analgesia (LIA) during total knee arthroplasty (TKA) through a prospective single-center randomized controlled trial, and to explore the safety and feasibility of high-dose glucocorticoids. Through this research, the investigators hope to provide an optimized solution for post-TKA pain management, improve patients' postoperative recovery and quality of life, and offer scientific evidence for pain management following TKA.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local; Arthroplasty, Replacement, Knee; Adrenal Cortex Hormones
• Intervention / Treatment: Drug: LIA with different doses of Diprospan

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chaofan Zhang, PhD; Phone Number: +86059187982113; Email: drcfzhang@fjmu.edu.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350004
      • Recruiting
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Chaofan Zhang, PhD; Phone Number: +86059187982113; Email: drcfzhang@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female participants aged 18 years or older;
2. Undergoing primary unilateral total knee arthroplasty (TKA)for unilateral knee osteoarthritis(OA)at ourhospital;
3. Preoperative American Society of Anesthesiologists(ASA)physical status classification of 1-3;
4. Ability to provide informed consent and sign a written informed consent form.

Exclusion Criteria:

1. Previous surgery on the operative knee or a history of infection in the operative knee;
2. Non-osteoarthritis conditions (including rheumatoid arthritis, traumatic arthritis, septic arthritis, and hemophilic arthritis);
3. Severe osteoarthritis (including flexion contracture >30° or varus/valgus deformity >30°);
4. Allergy to the relevant study drugs;
5. Presence of neuromuscular dysfunction in the ipsilateral limb;
6. Dependence on anesthetic drugs (defined as weekly use of opioids exceeding 100 mg morphine equivalents or local anesthetics for preoperative pain control for more than 3 months);
7. Poor systemic condition, including but not limited to: glycated hemoglobin (HbA1c) level >12%; blood pressure >170/110 mmHg (1 mmHg = 0.133 kPa); history of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure, or any acute coronary event within 6 months; dialysis or renal transplantation; pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose group; LIA with the addition of 3 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)	Drug: LIA with different doses of Diprospan; LIA with different doses of Diprospan
Experimental: Medium-dose group; LIA with the addition of 2 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)	Drug: LIA with different doses of Diprospan; LIA with different doses of Diprospan
Experimental: Low-dose group; LIA with the addition of 1 vial of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg)	Drug: LIA with different doses of Diprospan; LIA with different doses of Diprospan
No Intervention: Control group; LIA without the addition of Diprospan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Pain Score	VAS ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.	Preoperatively (baseline), and at 6 hours, 12 hours, 24 hours, 48 hours, 3 weeks, and 6 weeks postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score	Patient-reported outcome measuring pain, stiffness, and physical function in knee osteoarthritis. Total score ranges from 0 (best) to 96 (worst). Lower scores indicate better outcomes.	Preoperatively, and at 3 weeks and 6 weeks postoperatively.
range of motion	The range of motion (flexion and extension) of the operated knee will be measured using a standard goniometer. The primary outcome is the maximum active flexion angle (in degrees). A greater range of motion indicates better functional recovery.	Preoperatively, and at 3 weeks and 6 weeks postoperatively.
Total Postoperative Analgesic Consumption	The total consumption of all analgesic medications administered for postoperative pain control. All doses will be converted to morphine milligram equivalents (MME) for opioids (e.g.,tramadol) and to standardized dosages for non-opioid analgesics (e.g., ibuprofen, celecoxib, acetaminophen). The outcome will be reported as total MME (for opioids) and total standardized dosage (for non-opioids), both as continuous measures.	Within the first 48 hours postoperatively
. C-reactive Protein (CRP) Concentration	Serum CRP level measured in milligrams per liter (mg/L). A key marker of systemic inflammation.	Postoperative Day 1, Day 4, Week 3, and Week 6.
Erythrocyte Sedimentation Rate (ESR)	Erythrocyte sedimentation rate measured in millimeters per hour (mm/h). A nonspecific marker of inflammation.	Postoperative Day 1, Day 4, Week 3, and Week 6.
interleukin-6(IL-6)	Serum IL-6 level measured in picograms per milliliter (pg/mL). A pro-inflammatory cytokine.	Postoperative Day 1, Day 4, Week 3, and Week 6.
Alanine Aminotransferase (ALT) Concentration	Serum ALT level measured in units per liter (U/L). Elevated levels may indicate liver injury.	Postoperative Day 1, Day 4, Week 3, and Week 6.
Aspartate Aminotransferase (AST) Concentration	Serum AST level measured in units per liter (U/L). Elevated levels may indicate liver or muscle injury.	Postoperative Day 1, Day 4, Week 3, and Week 6.
Serum Creatinine Concentration	Serum creatinine level measured in micromoles per liter (μmol/L). Elevated levels may indicate impaired renal function.	Postoperative Day 1, Day 4, Week 3, and Week 6.
Blood Urea Nitrogen (BUN) Concentration	Blood urea nitrogen level measured in millimoles per liter (mmol/L). Elevated levels may be associated with dehydration or renal dysfunction.	Postoperative Day 1, Day 4, Week 3, and Week 6.
Incidence of Local Complications	The incidence of postoperative local complications at the surgical site, including but not limited to: wound exudation, poor wound healing, and periprosthetic joint infection. Incidence is defined as the number of participants experiencing at least one local complication, divided by the total number of participants in each group, expressed as a percentage.	0-6 months postoperatively
Incidence of Systemic Complications	The incidence of postoperative systemic complications, including but not limited to: nausea, vomiting, deep vein thrombosis (DVT), and acute liver failure. Incidence is defined as the number of participants experiencing at least one systemic complication, divided by the total number of participants in each group, expressed as a percentage.	0-6 months postoperatively

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: QT2025013-ZX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No